Who we serve
2SD Toxicology Services LLC specializes in the safety assessment of medical devices and diagnostic products. Our team is comprised of highly skilled professionals, including board-certified toxicologists, certified chemists, medical doctors, and laboratory scientists, who share a common goal of prioritizing patient safety in their work.
Our approach is grounded in data-driven safety assessments, and as our name suggests, our reports are based on rigorous statistical analysis. We adhere to the most up-to-date guidance from regulatory bodies such as the ISO, FDA, and EU-MDR for medical and in-vitro diagnostic devices.
With years of experience in biomedical research, we offer our clients confidence and guidance to ensure their products meet the highest safety standards.
Our mission is singular – safety of medical devices and IVD products
Biocompatibility evaluation of the Medical Devices
Toxicological evaluation of medical device and device-drug combination products
Clinical Evaluation Report of the IVD products
Chemical characterization study of the Medical Devices
Clinical laboratories lab directorship, compliance and accreditation activities
Bioanalytical method development and validation
Interpretation of the clinical toxicology report
Review of the litigation package sent by the Forensic Toxicology laboratory
High Resolution mass spectrometry training on assay development and validation
PK/PD studies and metabolite identification of the Drug
Computational toxicology and risk assessment
Clinical laboratories compliance and accreditation services
Software solution for compliance and quality management of laboratories